Sonlu Kantitatif Hassasiyet Sınırları ile Muayene Özelliklerinin İzlenmesinde Değiştirilmiş Q-Kontrol Şemasının Uygulanması: Kapsül Kabuğunda Bioburden Numaralandırması Örneği

Abstract

Yönetim karar verme desteğine ek olarak, süreçleri kontrol etmek, izlemek ve iyileştirmek için çeşitli iş alanlarında istatistiksel süreç kontrolü (SPC) metodolojilerinin uygulanması giderek daha önemli hale geldi. Bununla birlikte, pek çok inceleme özelliğinin sınırlı nicelik sınırları vardır ve bunun ötesinde sonuçlar, belirli seyreltme seviyesinden sonra sağlık bakım ürünlerindeki mikrobiyolojik yükün test edilmesi gibi " daha yüksek" olarak rapor edilir. 1:10, 1:50 veya 1: 100. Bu vaka çalışması, boş sert jelatin kapsülün ardışık teslimatlarının kalitesinin biyolojik yükünün izlenmesi için Laney tarafından değiştirilmiş öznitelik işlem-davranış şeması ile birleştirilmiş kalite skoru eğilim tablosu konseptinin uygulanmasını gösterdi. Mikrobiyolojik veri tabanı, Toplam Canlı Aerobik Sayımın (TVAC) ve Toplam Maya ve Küf Sayımının (TYMC) hem spesifikasyon limitlerine hem de minimum hassasiyet limitine göre aralıklara bölünmüştür. Her segmente düşük biyolojik yük değerinden başlayarak daha yüksek eşiğe kadar bir puan atandı. Veri seti modelinin ön araştırması, kaydın sıradan kontrol grafiğinin oluşturulması için herhangi bir varsayılan dağılımı takip etmediğini gösterdi. Veriler doğru (pozitif olarak) çarpıktır ve Poisson, binom veya normal dağılımı takip etmeye yönelik belirgin bir eğilim yoktur. Laney-Kalite çizelgesi, sapkın sonuçlar tespit edilerek CFU'lar sıralandıkça biyolojik yük içeriğini gösterdi.

Keywords

• Quality Score Chart,
• SPC,
• Truncated Distribution
• TVAC
• TYMC

Implementation of Modified Q-Control Chart in Monitoring of Inspection Characteristics with Finite Quantification Sensitivity Limits: A Case Study of Bioburden Enumeration in Capsule Shell

Abstract

Application of statistical process control (SPC) methodologies has become increasingly crucial in various business fields to control, monitor and improve processes, in addition to the support of the management decision-making. However, many inspection characteristics have limited quantification limits beyond which results are reported as either “< lower than” or “> higher than” such as testing of microbiological burden in healthcare products after definite dilution level ex. 1:10, 1:50 or 1:100. The present case study demonstrated the application of combined quality score trending chart concept with Laney-modified attribute process-behavior chart for monitoring the bioburden the quality of successive deliveries of empty hard gelatin capsule. Microbiological database was segmented into intervals based on both the specification limits and the minimum sensitivity limit of the Total Viable Aerobic Count (TVAC) and Total Yeast and Mold Count (TYMC). Each segment was assigned a score starting for low bioburden value to the higher threshold. Preliminary investigation of the dataset pattern showed that the record did not follow any presumed distribution for construction of the ordinary control chart. Data are right (positively) skewed with no apparent tendency to follow Poisson, binomial or normal distribution. Laney-Quality chart demonstrated bioburden contents as CFUs ranks with aberrant results spotted.

Keywords

• Quality Score Chart
• SPC
• Truncated Distribution
• TVAC
• TYMC

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